Sheila Shadbolt.jpg

Sheila Shadbolt

Associate

Education and Professional Membership

  • BSc Chemistry/Biochemistry
  • MSc Chemistry
  • Pg Dip Pharmaceutical Quality and Good Manufacturing Practice
  • Member of the Royal Society of Chemistry

Profile

Sheila has over 15 years’ experience in the pharmaceutical industry.  She is an EU Qualified Person and RP with experience in the manufacturing operations of both human and veterinary products within parenteral, non-sterile liquid, Vaccines & Biological product manufacture.  Sheila has held technical and quality leadership appointments in both Quality Assurance and Quality Control.

Sheila has extensive experience of Worldwide Regulatory Agency GMP/GDP expectations and current knowledge and understanding of regulatory requirements for medicinal product development, manufacture, and distribution of API and licensed medicinal products. She has hosted numerous regulatory inspections by the MHRA, VMD and FDA.

Based in South Africa, and specialising in the support of Emerging Markets and Global Supply Chain Activities, Sheila can provide the following support services:

  • Full Supply Chain Quality Auditing Services
  • Support of Due Diligence Activities
  • Qualified & Responsible Person Services
  • Quality Risk Management
  • Quality Management System Support and Review
  • Inspection Preparation and Remediation
  • QA/GMP Project Consultancy – Facility Refurbishment & Green Field Projects, Product Launches
  • GMP & GDP Training

     

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